PSI Spotlight 2024: Use of external data for safety review

May 16, 2024, 10:14 AM

Safety data is less often subject to statistical analysis but can we do better? In this session you will hear about four proposed methods (longitudinal Bayesian Dynamic Borrowing; a Bayesian meta-analytic combined approach using time-to-event modeling; the use of the posterior predictive distribution to help determine safety boundaries for various safety parameters; and the Bayesian approach of Brock et al. (Pharmaceutical Statistics, 2023)) designed to improve our inferences around safety data.


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